FDA-Device2024-10-02Class II
Custom Procedure Kit, REF: K12T-11077
Merit Medical Systems, Inc.
Hazard
7F sheath introducers labeled as 7.5F
Sold states
Worldwide - US Nationwide distribution in the states of WI, MN, TX, PA, GA, NE, CA, AR, MS, MA, MI, OH, CO, NV, OR, AZ, NC and the country of Mexico.
Affected count
24
Manufactured in
1600 W Merit Pkwy, South Jordan, UT, United States
Products
Custom Procedure Kit, REF: K12T-11077
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3191-2024Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief